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TYPE 2 DIABETES - National clinical guideline for management in primary and secondary care (update) pdf

TYPE 2 DIABETES
National clinical guideline for management
in primary and secondary care (update)
This is an update of the following
NICE (inherited) clinical guidelines on
Type 2 diabetes which were published in 2002:
E – retinopathy; F – renal disease; G – blood glucose;
H – management of blood pressure and blood lipids
The National Collaborating Centre
for Chronic Conditions
Funded to produce guidelines for the NHS by NICE
Published by
The recommendations on thiazolidinediones (R40 to R43, chapter 10), GLP-1 mimetic
(exenatide) (R44 to R46, chapter 10) and insulin therapy (R49 to R55), chapter 11) have been
updated and replaced by NICE short clinical guideline 87 ‘Type 2 diabetes: newer agents for
blood glucose control in type 2 diabetes’ (available at www.nice.org.uk/CG87shortguideline).
This short guideline contains details of the methods and evidence used to develop the updated
recommendations. Chapters 10 and 11 should be read in conjunction with the
short guideline.
Royal College of Physicians
The Royal College of Physicians plays a leading role in the delivery of high-quality patient care

by setting standards of medical practice and promoting clinical excellence. We provide physicians
in the United Kingdom and overseas with education, training and support throughout their
careers. As an independent body representing over 20,000 Fellows and Members worldwide, we
advise and work with government, the public, patients and other professions to improve health
and healthcare.
National Collaborating Centre for Chronic Conditions
The National Collaborating Centre for Chronic Conditions (NCC-CC) is a collaborative,
multiprofessional centre undertaking commissions to develop clinical guidance for the
National Health Service (NHS) in England and Wales. The NCC-CC was established in 2001.
It is an independent body, housed within the Clinical Standards Department at the Royal
College of Physicians of London. The NCC-CC is funded by the National Institute for Health
and Clinical Excellence (NICE) to undertake commissions for national clinical guidelines on
an annual rolling programme.
Citation for this document
National Collaborating Centre for Chronic Conditions. Type 2 diabetes: national clinical
guideline for management in primary and secondary care (update). London: Royal College of
Physicians, 2008.
ISBN 978-1-86016-333-3
ROYAL COLLEGE OF PHYSICIANS
11 St Andrews Place, London NW1 4LE
www.rcplondon.ac.uk
Registered charity No 210508
Copyright © 2008 Royal College of Physicians of London
All rights reserved. No part of this publication may be reproduced in any form (including photocopying or
storing it in any medium by electronic means and whether or not transiently or incidentally to some other use
of this publication) without the written permission of the copyright owner. Applications for the copyright
owner’s written permission to reproduce any part of this publication should be addressed to the publisher.
Typeset by Dan-Set Graphics, Telford, Shropshire
Printed in Great Britain by The Lavenham Press Ltd, Sudbury, Suffolk
iii
Contents
Members of the Guideline Development Group v
Acknowledgements vii
Preface viii
DEVELOPMENT OF THE GUIDELINE
1 Introduction
1.1 Background 3
1.2 Definition 4
1.3 Prevalence 4
1.4 Health and resource burden 5
2 Methodology
2.1 Aim 7
2.2 Scope 7
2.3 Audience 7
2.4 Involvement of people with Type 2 diabetes 8
2.5 Guideline limitations 8
2.6 Other work relevant to the guideline 8
2.7 Background 9
2.8 The process of guideline development 10
2.9 Disclaimer 14
2.10 Funding 14
3 Key messages of the guideline
3.1 Key priorities for implementation 15
3.2 Algorithms 16
4 Glossary and definitions 19
THE GUIDELINE
5 Education
5.1 Structured education 27
6 Lifestyle management/non-pharmacological management
6.1 Dietary advice 31
6.2 Management of depression 39
7 Glucose control levels
7.1 Clinical monitoring of blood glucose control 41
8 Self-monitoring of plasma glucose 47
9 Oral glucose control therapies (1): metformin, insulin secretagogues,
and acarbose
9.1 Clinical introduction 53
9.2 Metformin 53
9.3 Insulin secretagogues 65
9.4 Acarbose 79
9.5 Oral glucose control therapies; from evidence to recommendations 85
10 Oral glucose control therapies (2): other oral agents and exenatide
10.1 Clinical introduction 89
10.2 Thiazolidinediones (glitazones) 89
10.3 Gliptins (GLP-1 enhancers): dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitors) 114
10.4 Exenatide: GLP-1 mimetics 114
10.5 Oral glucose control therapies (2): other oral agents and exenatide; 120
from evidence to recommendations
11 Glucose control: insulin therapy
11.1 Oral agent combination therapy with insulin 125
11.2 Insulin therapy 130
11.3 Insulin detemir 146
11.4 Insulin delivery devices 146
12 Blood pressure therapy
12.1 Clinical introduction 151
12.2 Blood pressure lowering – targets and intervention levels 151
12.3 Blood pressure lowering medications 157
13 Cardiovascular risk estimation 181
14 Management of blood lipid levels
14.1 Overall clinical introduction 191
14.2 Targets and intervention levels 191
14.3 Statins and ezetimibe 193
14.4 Fibrates 198
14.5 Nicotinic acid and derivatives 205
14.6 Omega 3 fish oils 209
15 Antithrombotic therapy
15.1 Antiplatelet therapy 215
16 Kidney damage
16.1 Diabetes kidney disease management 223
17 Eye damage 233
18 Nerve damage
18.1 Diabetic neuropathic pain management 235
18.2 Autonomic neuropathy 246
18.3 Gastroparesis 247
18.4 Erectile dysfunction 250
18.5 Other aspects of autonomic neuropathy 255
19 Areas for future research 257
REFERENCES 259
iv
Type 2 diabetes
v
Members of the Guideline
Development Group
Professor Jonathan Mant (Chair)
Professor of Primary Care Stroke Research, University of Birmingham
Mrs Lina Bakhshi
Information Scientist, NCC-CC
Mrs Margaret Bannister
Nurse Consultant in Diabetes Care, Bradford and Airedale Primary Care Trust
Mrs Katherine Cullen
Health Economist, NCC-CC
Professor Melanie Davies
Professor of Diabetes Medicine, University of Leicester
Dr Jose Diaz
Health Services Research Fellow in Guideline Development, NCC-CC
Mrs Barbara Elster
Patient and Carer Representative, Essex
Dr Roger Gadsby
General Practitioner and Senior Lecturer in Primary Care, Warwickshire
Dr Anupam Garrib
Health Services Research Fellow, NCC-CC
Ms Irene Gummerson
Primary Care Pharmacist, Yorkshire
Dr Martin Hadley-Brown
General Practitioner Trainer, University of Cambridge
Professor Philip Home
Clinical Advisor to the GDG; Professor of Diabetes Medicine, Newcastle University
Mrs Kathryn Leivesley
Practice Nurse, North Manchester Primary Care Trust
Mrs Emma Marcus
Clinical Specialist Diabetes Dietitian, Hinckley and Bosworth Primary Care Trust
Mr Leo Nherera
Health Economist, National Collaborating Centre for Women’s and Children’s Health
Ms Roberta Richey
Health Services Research Fellow in Guideline Development, NCC-CC
Mr John Roberts
Patient and Carer Representative, Merseyside
Dr Mark Savage
Consultant Physician, North Manchester General Hospital
Lorraine Shaw
Paediatric Diabetes Clinical Nurse Specialist, Birmingham Children’s Hospital
Dr Stuart Smelie
Consultant Chemical Pathologist, Bishop Auckland General Hospital
Ms Nicole Stack
Guideline Development Project Manager, NCC-CC
Ms Claire Turner
Guideline Development Senior Project Manager, NCC-CC
Ms Susan Varney
Health Services Research Fellow in Guideline Development, NCC-CC
Dr Jiten Vora
Consultant Physician Endocrinologist, Royal Liverpool and Broadgreen University Hospital
The following experts were invited to attend specific meetings and to advise the Guideline
Development Group:
Dr Julian Barth
Consultant Chemical Pathologist, Leeds NHS Trust attended one meeting as a deputy for Dr
Stuart Smellie
Dr Indranil Dasgupta
Consultant Physician and Nephrologist, Birmingham Heartlands Hospital
Dr Michael Feher
Consultant Physician, Chelsea Westminster Hospital attended one meeting as a deputy for Dr
Mark Savage
Dr Charles Fox
Consultant Physician, Northampton General Trust attended one meeting as a deputy for
Professor Melanie Davies
Natasha Jacques
Principal Pharmacist Medicine, Solihull Hospital attended one meeting as a deputy for Ms
Irene Gummerson
Dr Eric Kilpatrick
Consultant Chemical Pathologist, University of Hull attended one meeting as a deputy for Dr
Stuart Smellie
Dr Ian Lawrence
Consultant Diabetologist, University of Leicester attended one meeting as a deputy for
Professor Melanie Davies and Dr Jiten Vora
Professor Sally Marshall
Professor of Diabetes, Newcastle University
Professor David Wood
Professor of Cardiovascular Medicine, Imperial College London
vi
Type 2 diabetes
Acknowledgements
The Guideline Development Group (GDG) is grateful to Bernard Higgins, Jane Ingham, Rob
Grant, Jill Parnham and Susan Tann of the NCC-CC for their support throughout the
development of the guideline.
The GDG would like to thank the following individuals for giving their time to advise us
regarding the design and interpretation of the economic model of analysis of third-line
therapy with insulins, glitazones or exenatide in Type 2 diabetes:
● Professor Alastair Gray, University of Oxford
● Dr Philip Clarke, University of Sydney
● Dr Joanne Lord, National Institute for Health and Clinical Excellence.
The GDG would like to thank the following individuals for peer reviewing the guideline:
● Professor Simon Heller, University of Sheffield
● Professor David Owens, Llandough Hospital, Penarth
● Professor Bryan Williams, University of Leicester
● Dr Miles Fisher, Glasgow Royal Infirmary
● Professor Soloman Tesfaye, University of Sheffield
● Mr Irvine Turner, Patient Representative.
vii
Acknowledgements
viii
Preface
In 2007, the Centers for Disease Control and Prevention in the USA took the step, unusual for
a non-infectious disease, of classifying the increase in the incidence of diabetes as an epidemic,
their projections suggesting that the prevalence of this already common disease will have
doubled by 2050. In the UK, diabetes already affects approximately 1.9 million adults overall,
and some estimates suggest that there are an additional 0.5 million with undiagnosed diabetes.*
This makes diabetes one of the commonest of all chronic medical conditions, and represents a
huge potential problem for our health services.
Over 90% of people with diabetes have Type 2 diabetes. This is still perceived as the milder
form, and while this may be true in some respects, such as the risk of ketoacidosis, the causation
of Type 2 diabetes is more complex and the management is not necessarily easier. Type 2
diabetes can cause severe complications, affecting the eye, the nervous system and the kidney.
The overall risk of cardiovascular disease is more than doubled, and life expectancy is reduced
by an average 7 years. In 2002, NICE published a suite of five guidelines dealing with different
aspects of the care of Type 2 diabetes. The rising prevalence of the disease, and the range of
complications which can arise, reinforce the importance of up-to-date guidance and accord-
ingly NICE have asked the National Collaborating Centre for Chronic Conditions (NCC-CC)
to produce this guideline, amalgamating and updating the previously published work.
The guideline is informed by extensive literature and covers many aspects of diabetes
management, although it is not intended to be a comprehensive textbook. It covers those topics
of particular relevance to life expectancy such as control of cholesterol and lipid levels, and
management of hypertension. It deals with major complications such as renal disease. There are
also key recommendations in areas of great importance to patients such as structured education
and the monitoring of glucose levels. Naturally, there are also sections dealing with control of
blood glucose levels and the use of the various drugs available for this purpose.
The guideline development group (GDG) have had a particularly difficult task during
development. The remit they were given was unusually large, and I have already mentioned the
vast amount of evidence which they were required to consider. They were required to
incorporate several existing NICE technology appraisals (TAs) within the guideline. In
addition, they had to contend with a major safety scare over one of the glucose lowering agents
which evolved over the course of guideline development. It is a measure of their commitment
and appetite for hard work that, despite the size of the existing task, they were frustrated rather
than relieved at not being able to include information about newer agents such as the DPP-4
inhibitors, the first of which was licensed towards the end of the development process (these
agents will be covered at a later date in a separate, short guideline). All at the NCC-CC are
extremely grateful to the GDG for the tremendous effort they have put into producing this
guideline on schedule. The challenge now is to implement its recommendations and to make a
genuine difference to the well-being and health of those with Type 2 diabetes.
Dr Bernard Higgins MD FRCP
Director, National Collaborating Centre for Chronic Conditions
* Department of Health. Health survey for England 2003. London: Stationary Office, 2004.
DEVELOPMENT OF
THE GUIDELINE
1 Introduction
1.1 Background
Diabetes is a group of disorders with a number of common features, of which raised blood
glucose is by definition the most evident. In England and Wales the four commonest types of
diabetes are:
● Type 1 diabetes
● Type 2 diabetes
● secondary diabetes (from pancreatic damage, hepatic cirrhosis, endocrinological
disease/therapy, or anti-viral/anti-psychotic therapy)
● gestational diabetes (diabetes of pregnancy).
This guideline is concerned only with Type 2 diabetes. The underlying disorder is usually that of
a background of insulin insensitivity plus a failure of pancreatic insulin secretion to compensate
for this.
The insulin insensitivity is usually evidenced by excess body weight or obesity, and exacerbated
by overeating and inactivity. It is commonly associated with raised blood pressure, a disturbance
of blood lipid levels, and a tendency to thrombosis. This combination is often recognised as the
‘metabolic syndrome’, and is associated with fatty liver and abdominal adiposity (increased waist
circumference).
The insulin deficiency is progressive over time, such that the high glucose levels usually worsen
relentlessly over a timescale of years, requiring continued escalation of blood glucose lowering
therapy. The worsening insulin deficiency with age also means that diabetes can appear in
elderly people who are quite thin. In some people in middle age the condition can be difficult
to distinguish from slow onset Type 1 diabetes.
In people whose hyperglycaemia has yet to be treated, glucose metabolism may be sufficiently
disturbed to cause symptoms, typically of polyuria, thirst, weight loss and fatigue. Diabetic coma
(ketoacidosis) is uncommon in Type 2 diabetes unless exacerbating factors (infection, drugs) are
present, but insulin deficiency and high sugar intake can lead to a related state (hyperosmolar
coma).
Type 2 diabetes is notable for the increased cardiovascular risk that it carries. This can be
manifest as coronary artery disease (heart attacks, angina), peripheral artery disease (leg
claudication, gangrene), and carotid artery disease (strokes, dementia). Many people with
Type 2 diabetes have the same risk of a cardiovascular event as someone without diabetes who
has already had their first heart attack; people with diabetes and a previous cardiovascular event
are at very high risk – around 10 times the background population. Accordingly management
of cardiovascular risk factors plays a large part in care of people with Type 2 diabetes, and is
particularly cost effective.
Because of the problems of maintaining good blood glucose control associated with the
increasing insulin deficiency, the degree of hyperglycaemia occurring in some individuals is
sufficient to give rise to a risk of the specific (‘microvascular’) complications of diabetes. Due
3
to early death caused by cardiovascular disease these are less common than in people with
Type 1 diabetes, but include eye damage (sometimes blindness), kidney damage (sometimes
requiring dialysis or transplantation), and nerve damage (resulting in amputation, painful
symptoms, erectile dysfunction, and other problems).
This situation of multiple vascular risk factors and multiple complications leads to multiple
targets for reduction of risk and improvement of health in people with Type 2 diabetes. Such
targets for management include obesity, activity levels, plasma glucose control, blood pressure
control, blood lipid control, reduction of thrombogenicity, laser therapy for eye damage, drug
therapy to delay kidney damage, local foot care, and symptomatic treatments for various types
of nerve damage. As a result diabetes care is typically complex and time consuming.
The necessary lifestyle changes, the complexities of management, and the side effects of
therapy, together make self-monitoring and education for people with diabetes central parts of
management.
1.2 Definition
The GDG worked to the World Health Organization (WHO) definition of diabetes, which
requires a degree of high plasma glucose levels sufficient to put the individual at risk of the
specific (microvascular) complications of diabetes. Diagnosis is not addressed in this guideline.
This definition was reconfirmed by the WHO in 2006, but, like earlier versions, does not
contain a specific definition for Type 2 diabetes.
2
People are normally thought to have Type 2 diabetes if they do not have Type 1 diabetes (rapid
onset, often in childhood, insulin-dependent, ketoacidosis if neglected) or other medical
conditions or treatment suggestive of secondary diabetes. However, there can be uncertainty in
the diagnosis particularly in overweight people of younger age. A further area of confusion is
the group of disorders classified as monogenetic diabetes – formally Maturity Onset Diabetes
of the Young (MODY) – which are usually not insulin requiring but which present in the first
decades of life.
It is noted that Type 1 diabetes with onset after childhood can be confused with Type 2 diabetes.
However, lower body weight, more rapid progression to insulin therapy, and absence of features
of the metabolic syndrome often give useful distinguishing clues.
1.3 Prevalence
The prevalence of diabetes in the UK is increasing as is the prevalence of obesity, decreased
physical activity, but also increased longevity after diagnosis thanks to better cardiovascular risk
protection. The current prevalence of Type 2 diabetes is unknown, and will vary with factors
such as mix of ethnic groups and degree of social deprivation.
4
Type 2 diabetes
Prevalence estimates vary from around 3.5 to 5.0%, the third edition of the International
Diabetes Federation (IDF) Atlas suggesting 4.0%, being 1.71 million in the 20- to 79-year-old
age group, of whom it is conventional to assume 85% have Type 2 diabetes.
4
Current prevalence
estimates are a poor pointer to future burden of diabetes due to their continuing increase. The
healthcare burden is also affected by the improved longevity of people with diabetes with better
management, which means that overall they carry a larger burden of complications and insulin
deficiency needing more complex care.
1.4 Health and resource burden
Type 2 diabetes can result in a wide range of complications (see above), with repercussions for
both the individual patient and the NHS. The economic impact of this disease includes at least
three factors:
● direct cost to the NHS and associated healthcare support services
● indirect cost to the economy, including the effects of early mortality and lost productivity
● personal impact of diabetes and subsequent complications on patients and their families.
Mortality attributed to people with diabetes is suggested as 4.2% of deaths in men and 7.7% of
deaths in women in the UK. These are likely to be underestimates as deaths from vascular events
such as stroke and myocardial infarction (MI) are notorious for under-recording of the
underlying causative disease. In a population-based study in Cardiff, at a time when population
prevalence was only 2.5%, deaths in people with diabetes accounted for over 10% of the total,
with around 60% attributable to diabetes.
5
Life years lost vary considerably with factors such as
blood glucose, blood pressure and blood lipid control, and smoking, as well as age, and can be
estimated by comparing United Kingdom Prospective Diabetes Study (UKPDS) risk engine
estimates to UK government statistical tables. Typically a 60-year-old man, newly diagnosed
and without existing arterial disease can expect to lose 8–10 years of life without proper
management.
5
1 Introduction
Men (≥55 years) Women (≥55 years)
General population (%) 4.3 3.4
Black Caribbean 10.0 8.4
Black African 5.0 2.1
Indian 10.1 5.9
Pakistani 7.3 8.6
Bangladeshi 8.2 5.2
Chinese 3.8 3.3
Irish 3.6 2.3
Table 1.1 The prevalence of doctor-diagnosed diabetes (2003)
3
The direct cost of Type 2 diabetes to the NHS is unknown, as much is classified as
cardiovascular or renal disease. However, with prevalence estimates of 3.5–5.0%, and healthcare
costs double those of the background population or more, estimates of 7–12% of total NHS
expenditure seem not unreasonable. The IDF Atlas notes that in industrialised countries
healthcare costs in people with diabetes tend to be double those of the background population.
This suggests a £2.8 billion attributable cost for the UK for 2007.
4
6
Type 2 diabetes
2 Methodology
2.1 Aim
The aim of the National Collaborating Centre for Chronic Conditions (NCC-CC) is to provide
a user-friendly, clinical, evidence-based guideline for the NHS in England and Wales that:
● offers best clinical advice for the management of Type 2 diabetes
● is based on best published clinical and economic evidence, alongside expert consensus
● takes into account patient choice and informed decision making
● defines the major components of NHS care provision for Type 2 diabetes
● details areas of uncertainty or controversy requiring further research
● provides a choice of guideline versions for differing audiences.
2.2 Scope
The guideline was developed in accordance with a scope, which detailed the remit of the
guideline originating from the Department of Health (DH) and specified those aspects of
Type 2 diabetes care to be included and excluded. The application of the guideline to children
has not been excluded but we were not able to specifically search for paediatric literature due to
volume of work. When health carers are applying these guidelines to children they need to use
their clinical judgement in doing so. For further assistance with applying this guideline to
children please refer to the British National Formulary (BNF) for children.
6
Prior to the commencement of the guideline development, the scope was subjected to stake-
holder consultation in accordance with processes established by the National Institute for
Health and Clinical Excellence (NICE).
1
The full scope is shown in appendix B. Available at
www.rcplondon.ac.uk/pubs/brochure.aspx?e=247
2.3 Audience
The guideline is intended for use by the following people or organisations:
● all healthcare professionals
● people with Type 2 diabetes and their parents and carers
● patient support groups
● commissioning organisations
● service providers.
7
2.4 Involvement of people with Type 2 diabetes
The NCC-CC was keen to ensure the views and preferences of people with Type 2 diabetes and
their carers informed all stages of the guideline. This was achieved by:
● having two people with Type 2 diabetes as patient representatives on the GDG
● consulting the Patient and Public Involvement Programme (PPIP) housed within NICE
during the pre-development (scoping) and final validation stages of the guideline project
● the inclusion of patient groups as registered stakeholders for the guideline.
2.5 Guideline limitations
The guideline has the following limitations.
● NICE clinical guidelines usually do not cover issues of service delivery, organisation or
provision (unless specified in the remit from the DH).
● NICE is primarily concerned with health services and so recommendations are not
provided for social services and the voluntary sector. However, the guideline may address
important issues in how NHS clinicians interface with these other sectors.
● Generally, the guideline does not cover rare, complex, complicated or unusual conditions.
● Where a meta-analysis was available, generally the individual papers contained within
were not appraised.
● It is not possible in the development of a clinical guideline to complete an extensive
systematic literature review of all pharmacological toxicity, although NICE expect their
guidelines to be read alongside the summaries of product characteristics (SPCs).
2.6 Other work relevant to the guideline
The guideline will update the following NICE technology appraisals (TAs) but only in relation
to Type 2 diabetes:
● ‘Guidance on the use of glitazones for the treatment of Type 2 diabetes’, NICE technology
appraisal guidance no. 63 (2003)
● ‘Guidance on the use of patient-education models for diabetes’, NICE technology appraisal
guidance no. 60 (2003)
● ‘Guidance on the use of long-acting insulin analogues for the treatment of diabetes –
insulin glargine’, NICE technology appraisal guidance no. 53 (2002).
Related NICE public health guidance:
● ‘Smoking cessation services, including the use of pharmacotherapies, in primary care,
pharmacies, local authorities and workplaces, with particular reference to manual
working groups, pregnant smokers and hard to reach communities’, Public health
programme guidance no. PH010 (February 2008)
● ‘Physical activity guidance for the Highways Agency, local authorities, primary care,
pharmacists, health visitors and community nurses, schools, workplaces, the leisure and
fitness industry and sports clubs’, Public health programme guidance no. PH008 (January
2007).
8
Type 2 diabetes
Related NICE clinical guidelines:
● ‘Cardiovascular risk assessment: the modification of blood lipids for the primary and
secondary prevention of cardiovascular disease’ (expected date of publication May 2008)
● ‘Diabetes in pregnancy: management of diabetes and its complications from pre-
conception to the postnatal period’, NICE clinical guideline no. 63 (2008)
● ‘Hypertension: management of hypertension in adults in primary care’ (partial update of
NICE CG18), NICE clinical guideline no. 34 (2006)
● ‘Obesity: the prevention, identification, assessment and management of overweight and
obesity in adults and children’, NICE clinical guideline no. 43 (2006)
● ‘Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people
and adults’, NICE clinical guideline no. 15 (2004, to be reviewed 2008)
● ‘Type 2 diabetes: prevention and management of foot problems’, NICE clinical guideline
no. 10 (2004).
Related TA guidance:
● ‘Guidance on the use of ezetimibe for the treatment of primary (heterozygous-familial
and non-familial) hypercholesterolaemia’, NICE technology appraisal guidance no. 132
(2007)
● ‘Guidance on the use of statins for the prevention of cardiovascular events in patients at
increased risk of developing cardiovascular disease or those with established
cardiovascular disease’, NICE technology appraisal guidance no. 94 (2006)
● ‘Guidance on the use of inhaled insulin for the treatment of Type 1 and Type 2 diabetes’,
NICE technology appraisal guidance no. 113 (2006)
● ‘Guidance on the use of clopidogrel and dipyridamole for the prevention of
artherosclerotic events’, NICE technology appraisal guidance no. 90 (2005)
● ‘Guidance on the use of the clinical effectiveness and cost effectiveness of insulin pump
therapy’, NICE technology appraisal guidance no. 57 (2003).
2.7 Background
The development of this evidence-based clinical guideline draws upon the methods described
by the NICE’s ‘Guideline development methods manual’
1
and the methodology pack
7
specifically developed by the NCC-CC for each chronic condition guideline (see
www.rcplondon.ac.uk/clinical-standards/ncc-cc/Pages/NCC-CC.aspx). The developers’ role
and remit is summarised in table 2.1.
9
2 Methodology
2.8 The process of guideline development
The basic steps in the process of producing a guideline are:
● developing clinical evidence-based questions
● systematically searching for the evidence
● critically appraising the evidence
● incorporating health economic evidence
● distilling and synthesising the evidence and writing recommendations
● grading the evidence statements
● agreeing the recommendations
10
Type 2 diabetes
NCC-CC The NCC-CC was set up in 2001 and is housed within the Royal
College of Physicians (RCP). The NCC-CC undertakes commissions
received from NICE.
A multiprofessional partners’ board inclusive of patient groups and
NHS management governs the NCC-CC.
NCC-CC Technical Team The technical team met approximately two weeks before each
GDG meeting and comprised the following members:
GDG Chair
GDG Clinical Adviser
Information Scientist
Two Research Fellows
Health Economist
Project Manager.
GDG The GDG met monthly (June 2006 to July 2007) and comprised a
multidisciplinary team of professionals and people with Type 2
diabetes who were supported by the technical team.
The GDG membership details including patient representation and
professional groups are detailed in the GDG membership table at the
front of this guideline.
Guideline Project Executive The Project Executive was involved in overseeing all phases of the
guideline. It also reviewed the quality of the guideline and compliance
with the DH remit and NICE scope.
The Project Executive comprises:
NCC-CC Director
NCC-CC Assistant Director
NCC-CC Manager
NICE Commissioning Manager
Technical Team.
Formal consensus At the end of the guideline development process the GDG met to
review and agree the guideline recommendations.
Members of the GDG declared any interests in accordance with the NICE technical manual.
1
A register is
given in appendix D, available online at www.rcplondon.ac.uk/pubs/brochure.aspx?e=247
Table 2.1 Role and remit of the developers
● structuring and writing the guideline
● updating the guideline.
s Developing evidence-based questions
The technical team drafted a series of clinical questions that covered the guideline scope. The
GDG and Project Executive refine and approve these questions, which are shown in appendix A.
Available at
www.rcplondon.ac.uk/pubs/brochure.aspx?e=247
s Searching for the evidence
The information scientist developed a search strategy for each question. Key words for the
search were identified by the GDG. In addition, the health economist searched for additional
papers providing economic evidence or to inform detailed health economic work (for example,
modelling). Papers that were published or accepted for publication in peer-reviewed journals
were considered as evidence by the GDG. Conference paper abstracts and non-English language
papers were excluded from the searches.
Each clinical question dictated the appropriate study design that was prioritised in the search
strategy but the strategy was not limited solely to these study types. The research fellow or
health economist identified titles and abstracts from the search results that appeared to be
relevant to the question. Exclusion lists were generated for each question together with the
rationale for the exclusion. The exclusion lists were presented to the GDG. Full papers
were obtained where relevant. See appendix A for literature search details. Available at
www.rcplondon.ac.uk/pubs/brochure.aspx?e=247
s Appraising the evidence
The research fellow or health economist, as appropriate, critically appraised the full papers. In
general, no formal contact was made with authors; however, there were ad hoc occasions when
this was required in order to clarify specific details. Critical appraisal checklists were compiled
for each full paper. One research fellow undertook the critical appraisal and data extraction.
The evidence was considered carefully by the GDG for accuracy and completeness.
All procedures are fully compliant with the:
● NICE methodology as detailed in the ‘Guideline Development Methods – Information for
National Collaborating Centres and Guideline Developers’ Manual
1
● NCC-CC quality assurance document and systematic review chart available at
www.rcplondon.ac.uk/clinical-standards/ncc-cc/Pages/NCC-CC.aspx.
s Health economic evidence
Areas for health economic modelling were agreed by the GDG after the formation of the clinical
questions. The health economist reviewed the clinical questions to consider the potential
application of health economic modelling, and these priorities were agreed with the GDG.
The health economist performed supplemental literature searches to obtain additional data for
modelling. Assumptions and designs of the models were explained to and agreed by the GDG
members during meetings, and they commented on subsequent revisions.
11
2 Methodology
s Distilling and synthesising the evidence and developing recommendations
The evidence from each full paper was distilled into an evidence table and synthesised into
evidence statements before being presented to the GDG. This evidence was then reviewed by
the GDG and used as a basis upon which to formulate recommendations. The criteria for
grading evidence are shown in table 2.2.
Evidence tables are available online at www.rcplondon.ac.uk/pubs/brochure.aspx?e=247
s Grading the evidence statements
s Agreeing the recommendations
The GDG employed formal consensus techniques to:
● ensure that the recommendations reflected the evidence base

approve recommendations based on lesser evidence or extrapolations from other situations
● reach consensus recommendations where the evidence was inadequate
● debate areas of disagreement and finalise recommendations.
The GDG also reached agreement on the following:
● five recommendations as key priorities for implementation
● five key research recommendations
● algorithms.
In prioritising key recommendations for implementation, the GDG took into account the
following criteria:
12
Type 2 diabetes
Table 2.2 Grading the evidence statements
1
Level of
evidence Type of evidence
1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of
bias.
1+
Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias.
1– Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias.*
2++ High-quality systematic reviews of case-control or cohort studies.
High-quality case-control or cohort studies with a very low risk of confounding, bias or
chance and a high probability that the relationship is causal.
2+ Well-conducted case-control or cohort studies with a low risk of confounding, bias or
chance and a moderate probability that the relationship is causal.
2– Case-control or cohort studies with a high risk of confounding, bias or chance and a
significant risk that the relationship is not causal.*
3 Non-analytic studies (for example case reports, case series).
4 Expert opinion, formal consensus.
*Studies with a level of evidence ‘–’ are not used as a basis for making a recommendation.
RCT, randomised controlled trial
● high clinical impact
● high impact on reducing variation
● more efficient use of NHS resources
● allowing the patient to reach critical points in the care pathway more quickly.
Audit criteria for this guideline will be produced for NICE by Clinical Accountability Service
Planning and Evaluation (CASPE) Research following publication in order to provide
suggestions of areas for audit in line with the key recommendations for implementation.
s Structuring and writing the guideline
The guideline is divided into sections for ease of reading. For each section the layout is similar
and contains the following parts.
● Clinical introduction sets a succinct background and describes the current clinical context.
● Methodological introduction describes any issues or limitations that were apparent when
reading the evidence base.
● Evidence statements provide a synthesis of the evidence base and usually describes what
the evidence showed in relation to the outcomes of interest.
● Health economics presents, where appropriate, an overview of the cost effectiveness
evidence base, or any economic modelling.
● From evidence to recommendations sets out the GDG decision-making rationale providing
a clear and explicit audit trail from the evidence to the evolution of the
recommendations.
● Recommendations provide stand alone, action-orientated recommendations.
● Evidence tables are not published as part of the full guideline but are available online at
www.rcplondon.ac.uk/pubs/brochure.aspx?e=247. These describe comprehensive details
of the primary evidence that was considered during the writing of each section.
s Writing the guideline
The first draft version of the guideline was drawn up by the technical team in accord with the
decisions of the GDG, incorporating contributions from individual GDG members in their
expert areas and edited for consistency of style and terminology. The guideline was then
submitted for a formal public and stakeholder consultation prior to publication. The registered
stakeholders for this guideline are detailed on the NICE website, www.nice.org.uk. Editorial
responsibility for the full guideline rests with the GDG.
13
2 Methodology
s Updating the guideline
Literature searches were repeated for all of the evidence-based questions at the end of the GDG
development process allowing any relevant papers published up until 16 April 2007 to be
considered. Future guideline updates will consider evidence published after this cut-off date.
Two years after publication of the guideline, NICE will ask a National Collaborating Centre
to determine whether the evidence base has progressed significantly to alter the guideline
recommendations and warrant an early update. If not, the guideline will be considered for
update approximately 4 years after publication.
2.9 Disclaimer
Healthcare providers need to use clinical judgement, knowledge and expertise when deciding
whether it is appropriate to apply guidelines. The recommendations cited here are a guide
and may not be appropriate for use in all situations. The decision to adopt any of the
recommendations cited here must be made by the practitioner in light of individual patient
circumstances, the wishes of the patient, clinical expertise and resources.
The NCC-CC disclaims any responsibility for damages arising out of the use or non-use of
these guidelines and the literature used in support of these guidelines.
2.10 Funding
The NCC-CC was commissioned by NICE to undertake the work on this guideline.
14
Type 2 diabetes
Full version Details the recommendations, the supporting evidence base and the
expert considerations of the GDG. Published by the NCC-CC.
Available at www.rcplondon.ac.uk/pubs/brochure.aspx?e=247
NICE version Documents the recommendations without any supporting evidence.
Available at www.nice.org.uk
‘Quick reference guide’ An abridged version.
Available at www.nice.org.uk
‘Understanding NICE A lay version of the guideline recommendations.
guidance’ Available at www.nice.org.uk
Table 2.3 Versions of this guideline
3 Key messages of the guideline
3.1 Key priorities for implementation
Offer structured education to every person and/or their carer at and around the time of
diagnosis, with annual reinforcement and review. Inform people and their carers that
structured education is an integral part of diabetes care.
Provide individualised and ongoing nutritional advice from a healthcare professional with
specific expertise and competencies in nutrition.
When setting a target glycated haemoglobin (GHb):
● involve the person in decisions about their individual HbA
1c
target level, which may be
above that of 6.5 % set for people with Type 2 diabetes in general
● encourage the person to maintain their individual target unless the resulting side effects
(including hypoglycaemia) or their efforts to achieve this impair their quality of life
● offer therapy (lifestyle and medication) to help achieve and maintain the HbA
1c
target
level
● inform a person with a higher HbA
1c
that any reduction in HbA
1c
towards the agreed
target is advantageous to future health
● avoid pursuing highly intensive management to levels of less than 6.5 %.
Offer self-monitoring of plasma glucose to a person newly diagnosed with Type 2 diabetes only
as an integral part of his or her self-management education. Discuss its purpose and agree how
it should be interpreted and acted upon.
When starting insulin therapy, use a structured programme employing active insulin dose
titration that encompasses:
● structured education
● continuing telephone support
● frequent self-monitoring
● dose titration to target
● dietary understanding
● management of hypoglycaemia
● management of acute changes in plasma glucose control
● support from an appropriately trained and experienced healthcare professional.
15
3.2 Algorithms
16
Type 2 diabetes
HbA
1c
≥6.5%* after trial
of lifestyle measures
Metformin
with active dose titration
HbA
1c
<6.5%*
HbA
1c
≥6.5%*
HbA
1c
≥7.5%*
HbA
1c
≥7.5%*
Monitor for expected
deterioration
Metformin + sulfonylurea
with active dose titration
Add thiazolidinedione or insulin
with active dose titration
Insulin + metformin + sulfonylurea
with active dose titration
Increase insulin dose and intensify
regimen with time
Monitor for expected deterioration
Monitor for expected deterioration
A sulfonylurea may be considered here for
people who are not overweight or if glucose levels
are particularly high
Exenatide may be considered here when body
weight is a special problem and recommendations
in the guideline are met
A rapid-acting insulin secretagogue may be
considered for people with non-routine daily
lifestyle patterns to assist in attaining glucose
control to their individual target
Only consider a thiazolidinedione here if
hypoglycaemia on sulfonylurea is a potential
problem
Figure 3.1 Scheme for the pharmacotherapy of glucose lowering in people with Type 2 diabetes
For details see recommendations on glucose lowering targets, clinical monitoring, use of oral agents, and use of
insulin
* or as individually agreed
17
3 Key messages
Figure 3.2 Scheme for the management of blood pressure (BP) for people with Type 2 diabetes
ACEI, angiotensin-converting enzyme inhibitor; A2RB, angiotensin 2 receptor blocker (sartan); CCB, calcium
channel blocker
Measure BP annually if not hypertensive or
renal disease
If >140/80 mmHg confirm consistently raised
Trial lifestyle measures alone unless
>140/90 mmHg
Maintain
lifestyle
measures
Start ACEI (and titrate dose)
(if African-Caribbean plus
diuretic or plus CCB)
Add CCB or diuretic
Add diuretic or CCB
Add α-blocker, β-blocker,
or potassium-sparing diuretic
Add α-blocker, β-blocker,
or potassium-sparing diuretic,
or refer to specialist
Above target
Above target
Above target
Above target
Above target
Above target
Targets
People with retinopathy or cerebrovascular
disease or with microalbuminuria:
follow algorithm with target <130/80 mmHg
Others:
follow algorithm with target <140/80 mmHg
Women with possibility of pregnancy:
avoid use of ACEI or A2RB drugs
Begin with CCB
In people with continuing intolerance to an
ACE inhibitor (other than renal deterioration or
hyperkalaemia):
Substitute the ACE inhibitor with an A2RB drug
People with microalbuminuria:
will already be on full dose of ACEI or alternative.
Then follow algorithm with target <130/80 mmHg
18
Type 2 diabetes
Figure 3.3 Diabetic symptomatic neuropathy management – a therapeutic summary
*Where neuropathic symptoms cannot be adequately controlled it is useful, to help individuals cope, to explain
the reasons for the problem, the likelihood of remission in the medium term, the role of improved blood glucose
control
Enquire annually for neuropathic symptoms (paraesthesia, burning sensations, shooting pains, other)
Add a trial of the cheapest (at maximum dose) of duloxetine, gabapentin, or pregabalin
– monitor for response
Consider a trial of another of duloxetine, gabapentin, or pregabalin – titrate dose and monitor for response
Review for opiate analgesia, pain clinical referral and psychological support
Monitor for worsening or remission
Controlled
Controlled
Controlled
Controlled
Uncontrolled*
Uncontrolled*
Uncontrolled*
Monitor for worsening or remission
Monitor for worsening or remission
Assess severity if present
(sleep disturbance, depression, interference with normal activities)
Maintain good blood glucose control
Non-severe
Offer local measures and simple analgesia
Monitor for worsening
Severe
Offer local measures and trial of tricyclic medication
Monitor for response

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